Overview
This study aims to assess the safety and effectiveness of telemedicine guided strategy on guideline-directed medical therapy (GDMT) optimization in hospitalized patients with heart failure in comparison to usual care in Switzerland.
Description
Heart failure (HF) is a chronic condition affecting approximately 26 million people worldwide, with acute decompensations leading to frequent hospitalizations and increased mortality. While guideline-directed medical therapy (GDMT) has been shown to improve outcomes in HF with reduced ejection fraction (HFrEF), real-world data indicate suboptimal implementation, with delayed initiation and low adherence to target doses. The STRONG-HF study demonstrated that rapid up-titration of GDMT following hospitalization significantly reduces HF-related mortality and readmission, highlighting the importance of early and structured treatment optimization. However, close monitoring during the vulnerable post-discharge phase remains resource-intensive and difficult to implement in routine care.
The DIGNITY study aims to assess the safety and effectiveness of a telemedicine-guided strategy for optimizing GDMT in patients with HFrEF compared to usual care in Switzerland after discharge. The study hypothesizes that telemedicine-supported management will improve GDMT optimization and clinical outcomes in this high-risk patient population.
Eligibility
Inclusion Criteria:
- Age > 18 years at the time of hospital admission
- Ability to use a (smart)phone and/or tablet for the follow-up
- Documented left ventricular ejection fraction (LVEF) > 40% assessed within preceding 12 months
- Not treated with optimal doses of oral HF therapies within 2 days before anticipated hospital discharge for acute HF in at least one of the medication categories (for details see Table 1 on page 10)
- Hospitalized due to acute HF decompensation.
- Specific measures within 24 hours prior to randomization
- Systolic blood pressure > 100 mmHg, and heart rate > 60bpm
- Serum potassium < 5mmol/L
Exclusion Criteria:
- Inability to use a (smart)phone or tablet
- Clear intolerance to high doses of betablockers, ACE inhibitors, or ARBs
- Estimated glomerular filtration rate <30ml/min/1.73m2 or dialysis
- Myocardial infarction, unstable angina or cardiac surgery within 3 months, percutaneous transluminal coronary intervention within 1 months prior to screening
- Cardiac resynchronization therapy device implantation within 3 months prior to screening
- Presence of significant obstructive lesion of the left ventricular outflow tract
- Amyloid cardiomyopathy
- Pregnant or nursing women